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Evaluation of the Union legislation on blood, tissues and cells


In the European Union (EU), millions of blood donations are collected every year by 1,400 blood establishments, enabling the transfusion of millions of blood components15,16. Plasma, a blood component, is also used for the manufacture of plasma derived medicinal products (PDMP). Tissues and cells17 are handled by over 4,000 tissue establishments18 and can also be the starting materials for the manufacture of medicinal products and medical devices. Several of these substances are exchanged between Member States.

Blood, tissues and cells (BTC) all come from the same source – donations from human beings – either during life or after death. They are processed, tested and stored in blood and tissue establishments before being supplied to hospitals and clinics. In most cases, no alternative treatments exist to save or enhance human lives. However, these substances can also cause adverse reactions in patients, including the transmission of disease.

To ensure high levels of public health protection for all stages of the process, the Blood Directive (2002/98/EC) and the Tissues and Cells Directive (2004/23/EC) were adopted in 2002 and 2004, respectively, laying down common (minimum) quality and safety standards at Union level and aiming to facilitate increased exchange of these substances between Member States. In this report, these two Directives are referred to jointly as ‘the basic Acts’. Implementing legislation was also adopted to provide technical requirements for both fields19. Since their adoption, some of the implementing Directives have been amended (see Annex IV).

There has been significant scientific and technological development in the sector and new risks of transmitting diseases, such as Zika, dengue fever and hepatitis E, have emerged since the legislation was adopted, more than 15 years ago. The field has also undergone organisational changes, including an increasing role of commercial players in a traditionally non-profit sector with a high level of public sector involvement. No evaluation of the basic Acts has taken place since their adoption. The European Commission has published several implementation reports for each sub-sector, each based on information provided by Member States. The most recent reports, published in April 201620,21 highlighted a number of gaps and shortcomings.

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